Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT03492151
Status
Recruiting
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Conditions

  • Pancreatic Cyst

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.

Key Dates

Start date
Oct 1, 2018
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
500 participants (estimated)

Primary Outcome Measure

Accuracy of PCL diagnosis [ Time Frame: 48 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Mayo Clinic Scottsdale CampusScottsdaleArizona85259
Veronica Oria
[email protected]
Rahul Pannala (PRINCIPAL_INVESTIGATOR)
Stanford HospitalStanfordCalifornia94305
Samer El-Dika
[email protected]
Samer El-Dika (PRINCIPAL_INVESTIGATOR)
Yale School of MedicineNew HavenConnecticut06510
Chloe Bennett
[email protected]
Thiruvengadam Muniraj, MD, MRCP (PRINCIPAL_INVESTIGATOR)
Parkview Hospital RandalliaFort WayneIndiana46805-
The Johns Hopkins HospitalBaltimoreMaryland21287
Anne Marie Lennon (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Roya Dastjerdi, MPH
[email protected]
Mandeep Sawhney, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthGarden CityNew York11530
Maria Marotta-Kollarus
[email protected]
Jessica Widmer, MD (SUB_INVESTIGATOR)
Tomas Gonda, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Sharon Slomovich
[email protected]
Frank Gress, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Wexner Medical CenterColumbusOhio43210
Megan Fry
[email protected]
614-293-1056
Baylor College of MedicineHoustonTexas77030
Chandra Kovvali
[email protected]
713-798-2308
Mohamed Othman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic Scottsdale Campus· Scottsdale, AZStanford Hospital· Stanford, CAYale School of Medicine· New Haven, CTParkview Hospital Randallia· Fort Wayne, INThe Johns Hopkins Hospital· Baltimore, MDBeth Israel Deaconess Medical Center· Boston, MA

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